EMA starts rolling review of a potential COVID-19 vaccine

The European Medicines Agency, EMA, has started a rolling review of trial data on a potential COVID-19 vaccine. The vaccine is from AstraZeneca with which the European Commission signed a purchase contract about a month ago on behalf of Denmark (among others).  

A month ago, the European Commission signed the first contract on a COVID-19 vaccine with vaccine manufacturer AstraZeneca. The European Medicines Agency, EMA, has now started a rolling review and assessment of the first vaccine data.

The rolling review is part of the EMA’s emergency plan, an administrative change that may be initiated to accelerate the evaluation of potential vaccines or medicines if the EMA assesses it to be critical for public health.

In a rolling review, the data from the different phases of vaccine development are assessed when generated instead of following the normal procedure of waiting for all data to become available.

First step towards a potential vaccine – but no conclusion

The data currently being reviewed by the EMA are data from the first laboratory tests of AstraZeneca’s prospective vaccine. These data cannot alone form the basis for drawing conclusions on the vaccine’s efficacy and safety. When all data from the final phases of vaccine development, including tests of the vaccine in human subjects, are ready and have been reviewed thoroughly, the EMA will announce its conclusion on the vaccine.  

The EMA’s decision to start a rolling review of AstraZeneca’s potential vaccine is based on interim results from non-clinical studies, i.e. laboratory studies and animal testing, and from early clinical trials, i.e. trials in human subjects, so far indicating that the vaccine triggers the production of antibodies and T cells (cells in the immune system, the body’s defence against infection) targeting the virus.

Vaccine presently tested in comprehensive trials with human subjects

Major clinical trials with several thousands of trial subjects are being conducted right now to test the vaccine, and the results of these trials are expected to become available in the coming weeks and months.

All available data on the safety of the vaccine coming from these trials as well as data on the vaccine’s quality, such as active substances and excipients and the way they are produced, will also be thoroughly reviewed.

The EMA’s assessment of data on COVID-19 vaccines will follow the usual high standards for assessing quality, safety and efficacy.

Read more:

EMA’s press release: EMA starts first rolling review of a COVID-19 vaccine in the EU [link]

News on the DKMA website, 14 August 2020: First deal secured on the supply of a potential COVID-19 vaccine (in Danish only)